摘要 |
<P>PROBLEM TO BE SOLVED: To provide stable pharmaceutical compositions useful for administering methylnaltrexone that is a quaternary amine opioid antagonist derivative, and methods for making the same. <P>SOLUTION: A pharmaceutical preparation contains methylnaltrexone or a salt thereof, and a solution of at least one degradation inhibiting agent of methylnaltrexone selected from the group consisting of a chelate agent, a buffering agent, an antioxidant, and a combination thereof, wherein the preparation has the concentration of methylnaltrexone degradation products that does not exceed 2% of the methylnaltrexone or salt thereof in the preparation. <P>COPYRIGHT: (C)2012,JPO&INPIT |